EnteraSense secures CE Mark for PillSense, paving the way for European launch
EnteraSense has reached an important new regulatory milestone, with PillSense™ receiving EU MDR CE Mark approval and paving the way for the company’s European product launch.
The Galway-based medical device company has developed PillSense, a swallowable capsule designed to rapidly detect blood in the upper gastrointestinal tract and support clinicians in the triage and management of patients with suspected upper GI bleeding. The system combines a single-use ingestible capsule with a reusable receiver, providing clinicians with an easy-to-interpret result to support faster clinical decision-making.
The CE Mark builds on EnteraSense’s progress in the US, where PillSense has already received FDA authorisation and is commercially distributed through Cook Medical.
Securing regulatory pathways in both the US and Europe represents an important step in EnteraSense’s continued commercialisation of PillSense and its ambition to improve the identification and management of suspected upper GI bleeding.
Congratulations to Donal and the entire EnteraSense team on the milestone.
EnteraSense is currently fundraising through Venturebeam. We invite you to explore the EnteraSense deal on the platform to learn more about the company and its current funding round. If you would like to discuss the opportunity in more detail, the Venturebeam team would be very happy to hear from you and provide any additional information.
